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United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Washington, DC 

20250 

VETERINARY SERVICES MEMORANDUM NO. 800.113 

TO: VS Management Team (VSMT) 

 Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

FROM: John R. Clifford /s/ John R. Clifford 9/17/08 

 Deputy Administrator 

 Veterinary Services 

SUBJECT: Production, Testing and Storage of Master Seed and Master Cell Stocks at 

 Alternate Locations 

I. PURPOSE 

The purpose of this memorandum is to provide guidance regarding production, testing, 

and storage of Master Seeds and Master Cell stocks at locations other than the facility 

licensed to sell and distribute the related veterinary biologic. 

II. DEFINITIONS 

Applicable 9 CFR Definitions 

 

 A. Master Seed (MS) 9 CFR 101.7(a) – An organism at a specific passage level 

 which has been selected and permanently stored by the producer from which all 

 other seed passages are derived within permitted levels. 

 B. Master Cell Stock (MCS) 101.6(d) – The supply of cells of a specific passage 

 level from which cells for the production of biologics originate. 

III. BACKGROUND 

Seed and cell stocks prepared for designation and use as an MS or MCS may be produced 

at the licensed establishment that manufactures the products or obtained from other 

sources such as other licensees, research and development firms, and universities. 

 

In the case of products that are imported to the United States for distribution and sale, the 

MS and MCS are often produced and stored at a foreign manufacturing facility. Refer to 

VS Memorandum 800.101, U.S. Veterinary Biological Product Permits for Distribution 

and Sale, for more information. 
VETERINARY SERVICES MEMORANDUM NO. 800.113 

 Page 2 

Since products must be produced from the designated passage levels of MS and/or MCS, 

this material may be stored at several different locations within the licensed facility 

and/or, with APHIS permission, portions may even be stored off licensed premises. 

IV. GUIDELINES 

 A. The use of MS and MCS produced and/or tested by other sources or stored at 

alternate locations is permissible. The following guidelines are applicable to such 

MS or MCS: 

1. The licensee is responsible for maintaining copies of all records pertaining to 

the source and/or characterization of the MS and MCS. 

2. MS and MCS obtained from other sources must be shipped to the licensed 

facility accompanied by any applicable permits. Permit restrictions must be 

followed, and documentation related to the movement of the organism or cell 

stock must be maintained. 

3. Once the MS and MCS are located at the licensed establishment, the licensed 

establishment assumes all responsibility for the MS and MCS and compliance 

with applicable regulations. Starting inventory received by the licensee must 

be documented and all uses of this material recorded. 

4. The licensee is responsible for all 9 CFR-required testing of the MS and MCS, 

including any testing performed by contractors. Records (including bench 

records) of all 9 CFR-required testing used to support MS and MCS approval 

must be maintained by the licensed firm. The MS and MCS reports, 

submitted as per Veterinary Services Memorandum 800.109, should be 

submitted by the licensed firm. 

B. Storage of MS and MCS off licensed premises – A licensee must request APHIS 

permission to store a portion of the MS and MCS at a secure, alternate location. 

The request should be submitted to CVB Inspection and Compliance regarding 

storage at sites other than the licensed establishment. The request should include 

the following information: 

 1. Identification of the MS and MCS, including a description of the storage 

 containers, 

 2. Amount of inventory to be stored at alternate storage location, 

 3. How the containers of MS and MCS are to be secured and made tamper 

 evident, 
VETERINARY SERVICES MEMORANDUM NO. 800.113 

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 4. Storage conditions for MS and MCS containers, and 

 5. An addendum to the plot plan legend including the following information: 

 a. Name and address of alternate storage location. 

b. Permission to inspect off-site location by APHIS inspectors or foreign 

inspectors acting on behalf of APHIS. If the storage site is at another 

licensed facility, both establishments must submit a request for an 

exemption to 9 CFR 114.3(b). The licensee receiving the MS and/or MCS 

for storage must update their facility documents to include the storage of 

this material.